United States - English - NLM (National Library of Medicine)

novo nordisk - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: novolog mix 70/30 is contraindicated: risk summary there are no available data with novolog mix 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day,

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [usp'u] in 1 ml - novolin 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. limitations of use: in novolin 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. novolin 70/30 is contraindicated: risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin n is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolin n is contraindicated: risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations diseas

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolog is contraindicated: risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those observed in rats

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb) - insulin degludec 100 u in 1 ml - tresiba is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. limitations of use tresiba is contraindicated: risk summary available data from one unpublished trial and the published literature with tresiba use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label actively controlled clinical trial that included 91 pregnant women with type 1 diabetes who were administered tresiba once daily and insulin aspart, beginning in gestational weeks 8 to 13 or prior to conception, no clear evidence of maternal or fetal risk associated with tresiba use was observed (see data ). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). rats and rabbits were exposed to insulin degludec in animal reproduction studies during organogenesis. pre-and post-implantation losses and vi

United States - English - NLM (National Library of Medicine)

tya pharmaceuticals - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin r is indicated to improve glycemic control in adults and children with diabetes mellitus. novolin r is contraindicated: pregnancy category b: all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good glycemic control. it is essential for patients with diabetes or a history of gestational diabetes to maintain good glycemic control before conception and throughout pregnancy. insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is important during pregnancy in patients with diabetes. therefore, women should be advised to tell their healthcare provider if they intend to become, or if they become, pregnant while taking novolin r. no reproductive toxicity studies have been performed with novolin r. it 

United States - English - NLM (National Library of Medicine)

tya pharmaceuticals - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. novolog is contraindicated pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is essential in these patients. therefore, female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking novolog. an open-label, randomized study compared the safety and efficacy of novolog (n=157) vers

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin r is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolin r is contraindicated: risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations diseas

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 100 [iu] in 1 ml - levemir is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use levemir is not recommended for the treatment of diabetic ketoacidosis. levemir is contraindicated: risk summary available data from published studies and postmarketing case reports with levemir use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label clinical trial that included 152 pregnant women with type 1 diabetes who were administered levemir once or twice daily, beginning in gestational weeks 8 to 12 or prior to conception, no clear evidence of maternal or fetal risk associated with levemir was observed (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were conducted in non-diabetic pregnant rats and rabbits with insulin detemir administrat

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 14.2 mg in 1 ml - levemir is indicated to improve glycemic control in adults and children with diabetes mellitus. important limitations of use: - levemir is not recommended for the treatment of diabetic ketoacidosis. intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition. levemir is contraindicated in patients with hypersensitivity to levemir or any of its excipients. reactions have included anaphylaxis [see warnings and precautions (5.4) and adverse reactions (6.1) ] pregnancy category c: in a fertility and embryonic development study, insulin detemir was administered to female rats before mating, during mating, and throughout pregnancy at doses up to 300 nmol/kg/day (3 times a human dose of 0.5 units/kg/day, based on plasma area under the curve (auc) ratio). doses of 150 and 300 nmol/kg/day produced numbers of litters with visceral anomalies. doses up to 900 nmol/kg/day (approximately 135 times a human dose of 0.5 units/kg/day based on auc ratio) were given to rabbits during organoge